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Prior Authorization Protocol FYCOMPA (perampanel) NATL Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document. I. FDA Approved Indications: Adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older Adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older II. Health Net Approved Indications and Usage Guidelines: Diagnosis of partial-onset seizures OR Diagnosis of primary generalized tonic-clonic seizures AND III. Coverage is Not Authorized For: IV. Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature General Information: V. Patient is receiving treatment with at least one other antiepileptic drug (AED) This section intentionally left blank Therapeutic Alternatives: Drug Gabitril® (tiagabine) levetiracetam (Keppra®) lamotrigine (Lamictal®) Lyrica® (pregabalin)* gabapentin (Neurontin®) Dosing Regimen 32 - 56 mg PO QD in 2 - 4 divided doses in patients on enzyme-inducing AEDs Patients not on enzyme-inducing AEDs require lower doses 1000 – 3000 mg PO QD in two divided doses 100 - 500 mg PO QD in 2 divided doses depending on utilization of other AEDs that may induce enzymes or glucuronidation 150 – 600 mg PO QD in 2 – 3 divided doses 900 – 1800 mg PO QD in 3 divided doses Dose/Limit/Maximum Dose 56 mg daily 3000 mg daily 500 mg daily 600 mg daily 1800 mg daily (PI notes that up to 2400 mg QD Confidential and Proprietary Draft Prepared: 11.15.12 S Redline Approved by Health Net Pharmacy & Therapeutics Committee: 02.20.13, 11.20.13, 11.19.14, 11.18.15 Revised: 06.10.13 M. Hashemian, 06.26.14 H Tan, 06/25/15 D.Duane, 05.20.16 M Hashemian Page -1 Prior Authorization Protocol FYCOMPA (perampanel) NATL Drug Sabril® (vigabatrin) topiramate (Topamax®) oxcarbazepine (Trileptal®) Potiga™ (ezogabine) Dosing Regimen 1 – 3 gm PO QD in 2 divided doses Dose/Limit/Maximum Dose tolerated in long-term studies, and up to 3600 mg QD tolerated in shortterm studies.) 3 gm daily 200 – 400 mg PO QD in 2 divided doses 400 mg daily 600 – 1200 mg PO QD in 2 divided doses 1200 mg daily (2400 mg daily slightly more effective than 1200 mg, but not well tolerated in clinical trials.) 400 mg TID Initial dose - 100 mg TID; increase by no more than 50 mg TID at weekly intervals. 800-1200 mg PO QD in 2 divided doses carbamazepine (Tegretol®, Tegretol® XR) phenytoin 100-600 mg PO QD in 2 or 3 divided (Dilantin®) doses valproic acid 10-60 mg/kg/day PO (Depakene®) divalproex (Depakote®) *Requires Prior Authorization VI. 1600 mg daily 600 mg daily 60 mg/kg daily Recommended Dosing Regimen and Authorization Limit: Drug Dosing Regimen Confidential and Proprietary Draft Prepared: 11.15.12 S Redline Approved by Health Net Pharmacy & Therapeutics Committee: 02.20.13, 11.20.13, 11.19.14, 11.18.15 Revised: 06.10.13 M. Hashemian, 06.26.14 H Tan, 06/25/15 D.Duane, 05.20.16 M Hashemian Authorization Limit Page -2 Prior Authorization Protocol FYCOMPA (perampanel) NATL Drug Fycompa Dosing Regimen Partial-Onset Seizures Starting dose is 2 mg PO QHS in patients not on enzymeinducing AEDs and 4 mg in patients on enzyme-inducing AEDs. Authorization Limit Length of Benefit May increase based on clinical response and tolerability by a maximum of 2 mg PO QHS in weekly increments to a dose of 4 mg to 12 mg PO QHS. Dose increases should occur no more frequently than at weekly intervals. Maximum recommended daily dose is 12 mg PO QHS. Primary Generalized Tonic-Clonic Seizures Starting dose is 2 mg PO QHS in patients not on enzymeinducing AEDs and 4 mg in patients on enzyme-inducing AEDs. May increase based on clinical response and tolerability by a maximum of 2 mg PO QHS in weekly increments to a dose of 4 mg to 12 mg PO QHS. Dose increases should occur no more frequently than at weekly intervals. Maximum recommended daily dose is 12 mg PO QHS. VII. Product Availability: Fycompa tablets: 2, 4, 6, 8, 10, and 12 mg Fycompa Oral Suspension: 0.5 mg/ml VIII. References: 1. Fycompa [Prescribing Information]. Woodcliff Lake, NJ: Eisai Inc.; April 2016. 2. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 20, 2016. The materials provided to you are guidelines used by this health plan to authorize, modify, or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual needs and the benefits covered under your contract. Confidential and Proprietary Draft Prepared: 11.15.12 S Redline Approved by Health Net Pharmacy & Therapeutics Committee: 02.20.13, 11.20.13, 11.19.14, 11.18.15 Revised: 06.10.13 M. Hashemian, 06.26.14 H Tan, 06/25/15 D.Duane, 05.20.16 M Hashemian Page -3